Illumina, Amgen to Develop CDx for Colorectal Cancer

Illumina is following up its big news earlier this week that its new HiSeq X10 system can make the $1,000 genome possible by announcing a partnership with Amgen to develop and commercialize a multigene, next-generation sequencing-based test as a companion diagnostic for Amgen's anticancer drug Vectibix (panitumumab). The firms plan to seek premarket approval of the test by the FDA and other regulatory agencies per the agreement.

Vectibix is a fully human anti-EGFR monoclonal antibody therapeutic designed to treat metastatic colorectal cancer. The aim of the collab, according to the companies, will be to validate a test platform that can identify the RAS mutation status of patients who would be good candidates for treatment with Vectibix. The test will be developed for use with Illumina's MiSeqDx™ instrument, and Illumina plans to commercialize the test with a focus on U.S. and EU markets pending regulatory approval in both locations.

Nick Naclerio, svp, corporate and venture development and general manager of Illumina's Enterprise Informatics, said in a statement that this agreement is part of the company's strategy to bring NGS to the clinical diagnostics field.

"With three FDA-cleared NGS products in our portfolio, we intend to complement internal development programs by taking products developed with external partners through the FDA submission process. Amgen is a key partner given their leadership in therapeutic development and strong track record in commercializing novel products," he added.